Anifrolumab Approved for Moderate to Severe Systemic Lupus Erythematosus

Officials with the FDA have approved anifrolumab (Saphnelo, AstraZeneca) for the treatment of adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy, according to a press release from AstraZeneca.

SLE is the most common form of lupus, impacting up to 300,000 individuals in the United States, according to the press release. It disproportionately affects African American, Hispanic, and Asian populations, and can affect any organ. Patients often experience debilitating symptoms, long-term organ damage, and poor health-related quality of life.

“Our treatment goals in systemic lupus erythematosus are to reduce disease activity; prevent organ damage from either the illness itself o the medications, especially steroids; and improve one’s quality of life,” said Richard Furie, MD, a principal investigator in the Saphnelo clinical development program, in the press release. “Today’s approval of anifrolumab represents a big step forward for the entire lupus community.”

Anifrolumab is a first-in-class type I interferon receptor antibody and is the only new treatment in more than a decade for this patient population. Type 1 interferon plays a central role in the pathophysiology of lupus and increased signaling is associated with rising disease activity and severity. The approval was based on data from the Saphnelo clinical development program, which includes the TULIP-1 and -2 phase 3 trials and the MUSE phase 2 trial.

In the TULIP-2 trial, 362 eligible patients were randomized to receive either a fixed-dose intravenous infusion of 300 mg anifrolumab or a placebo every 4 weeks, and investigators assessed the effect of the drug in reducing disease activity. In the TULIP-1 trial, 457 patients received either a fixed-dose infusion of 150 mg anifrolumab, a 300 mg infusion of anifrolumab, or a placebo every 4 weeks, in addition to standard therapy. This trial did not meet its primary endpoint based on the SLE Responder Index 4 composite measure.

The MUSE phase 2 trial evaluated the efficacy and safety of 2 doses of anifrolumab compared to placebo. In the trial, 305 adults were randomized and received a fixed-dose intravenous infusion of 300 mg anifrolumab, 1000 mg anifrolumab, or placebo every 4 weeks, in addition to standard therapy, for 48 weeks. Researchers found improvement compared to placebo across multiple efficacy endpoints with both arms receiving standard therapy.

According to the press release, more patients in these trials who received anifrolumab experienced a reduction in overall disease activity across organ systems, including skin and joints. These patients also achieved sustained reduction in oral corticosteroid use compared to patients receiving a placebo, with both groups receiving standard therapy.

“Physicians will now be able to offer an effective new treatment that has produced significant improvements in overall disease activity, while reducing corticosteroid use,” Furie said in the press release.

Adverse reactions that occurred more frequently in patients receiving anifrolumab in the 3 clinical trials included nasopharyngitis, upper respiratory tract infection, bronchitis, infusion-related reactions, herpes zoster, and cough.

“Today’s landmark approval of Saphnelo is the combination of years of AstraZeneca’s pioneering research in the type 1 interferon pathway, a central driver in systemic lupus erythematosus pathophysiology,” said Mene Pangalos, PhD, executive vice president of BioPharmaceuticals Research & Development at AstraZeneca, in the press release. “This ground-breaking medicine has the potential to meaningfully improve the lives of patients living with this often-debilitating disease.”

REFERENCE

Saphnelo (anifrolumab) approved in the US for moderate to severe systemic lupus erythematosus. News release. August 2, 2021; AstraZeneca. Accessed August 2, 2021. https://www.astrazeneca.com/media-centre/press-releases/2021/saphnelo-approved-in-the-us-for-sle.html